Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization - Full Text View

Purpose

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

Condition	Intervention
ST-elevation Myocardial Infarction. Multi Vessel Disease.	Procedure: Percutaneous coronary intervention Procedure: FFR


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Thomas Engstrom, Rigshospitalet, Denmark:

Primary Outcome Measures:

All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ]
Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure

Secondary Outcome Measures:

Cardiac death or myocardial infarction [ Time Frame: 1 year ]
Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ]
Angina status and quality of life [ Time Frame: 1 year ]
Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ]
Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ]
Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ]


Estimated Enrollment:	650
Study Start Date:	May 2011
Estimated Study Completion Date:	February 2019
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Culprit lesion revascularization Only the culprit lesion is treated whereas other study lesions are left un-treated.	Procedure: Percutaneous coronary intervention
Active Comparator: Full revascularization Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.	Procedure: Percutaneous coronary intervention Procedure: FFR

Detailed Description:

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years.
Acute onset of chest pain of < 12 hours' duration.
ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
Culprit lesion in a major native vessel.
MVD (non-culprit vessels with angiographic stenosis >50%)
Successful primary PCI

Exclusion Criteria:

Pregnancy.
Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
Inability to understand information or to provide informed consent.
Haemorrhagic diathesis or known coagulopathy.
Stent thrombosis
Significant left main stem stenosis
Cardiogenic shock at admittance

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960933

Locations


Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Aalborg Universitetshospital

Investigators


Study Chair:	Steffen Helqvist, MD, DMSci	Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator:	Thomas Engstrøm, MD, DMSci	Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator:	Henning Kelbæk, MD. DMSci	Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator:	Lars Køber, MD, Prof., DMSci	Rigshospitalet, University of Copenhagen, Denmark

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3—PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71.

Høfsten DE, Kelbæk H, Helqvist S, Kløvgaard L, Holmvang L, Clemmensen P, Torp-Pedersen C, Tilsted HH, Bøtker HE, Jensen LO, Køber L, Engstrøm T; DANAMI 3 Investigators. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. Am Heart J. 2015 May;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004. Epub 2015 Feb 14.


Responsible Party:	Thomas Engstrom, MD, Senior Consultant, DMSCi, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01960933 History of Changes
Other Study ID Numbers:	DANAMI-3-PRIMULTI
Study First Received:	October 9, 2013
Last Updated:	October 17, 2016

Keywords provided by Thomas Engstrom, Rigshospitalet, Denmark:


STEMI MVD Full revascularization Culprit lesion revascularization only Primary PCI

Additional relevant MeSH terms:


Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on July 17, 2017

Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)